Trial Summary
What is the purpose of this trial?This trial tests a new drug, GSBR-1290, in overweight/obese people and those with Type 2 Diabetes on Metformin. It aims to see if the drug is safe and how it affects the body, including its impact on blood sugar and weight.
Eligibility Criteria
This trial is for adults aged 18-75 who are overweight or obese with a BMI of 27-40 kg/m2, and those with Type 2 Diabetes Mellitus on stable metformin treatment. Participants should not use nicotine, have good venous access for blood sampling, and no significant health issues like heart or kidney disease.Inclusion Criteria
I am between 18 and 75 years old.
I have been on a stable dose of metformin (≥500 mg) for at least 6 months, with my HbA1c between 7.0% and 10.5%.
I am between 18 and 75 years old.
I am an adult with a BMI between 27 and 40.
Exclusion Criteria
I have a history of heart rhythm problems or abnormal ECG results.
My blood pressure is high or my heart rate is too low or too high after resting.
My liver tests are more than twice the normal limit.
I have not had any major illnesses or surgeries in the last 3 months.
My kidney function is reduced.
Treatment Details
The study tests GSBR-1290's safety and effects compared to a placebo in overweight/obese individuals and those with Type 2 Diabetes over three months. It will look at how the body processes the drug (PK) and its impact on the body (PD).
5Treatment groups
Experimental Treatment
Group I: Cohort 5Experimental Treatment2 Interventions
Participants with T2DM(Cohort 5) will be randomized to placebo, low-dose, or high-dose arms. Participants in the low-dose, high-dose or placebo arms will receive multiple-ascending doses for 12 weeks
Group II: Cohort 4Experimental Treatment2 Interventions
HOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks
Group III: Cohort 3Experimental Treatment2 Interventions
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Group IV: Cohort 2Experimental Treatment2 Interventions
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Group V: Cohort 1Experimental Treatment2 Interventions
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Find a clinic near you
Research locations nearbySelect from list below to view details:
QPS Miami Research AssociatesMiami, FL
Anaheim Clinical TrialsAnaheim, CA
Progressive Medical ResearchPort Orange, FL
ProSciento, IncChula Vista, CA
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Who is running the clinical trial?
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure TherapeuticsLead Sponsor
Gasherbrum Bio, IncLead Sponsor